DOCSLIB.ORG

Perceived and Potential Human Health Risks Associated with Consumption of Genetically Modified Animals

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Perceived and Potential Human Health Risks Associated with Consumption of Genetically Modified Animals MARCH 2013 Perceived and Potential Human Health Risks Associated with Consumption of Genetically Modified Animals Corinne Krentz1 Summary • The GM EnviropigTM produces an • Numerous varieties of genetically enzyme that enables phosphate modified (GM) crops have been absorption and utilization, thus reducing approved in Canada, and processed phosphate content of manure and foods containing GM ingredients can environmental effects associated with be found on grocery store shelves. In excess phosphate. No adverse effects contrast, there are currently no GM resulting from consumption of this animals or products derived from GM enzyme have been reported. animals approved for human consumption in Canada. • To date, there is little evidence that GM animals pose a significantly greater risk • According to the principle of to human health than their unmodified substantial equivalence, which is used counterparts in terms of allergenicity, to evaluate the safety of GM foods, anti-nutrient effects or acute toxicity. the genetically modified product must However, there is some uncertainty be at least as safe as its unmodified regarding long-term health effects. counterpart. Common types of health effects include protein allergenicity, anti-nutrient properties and toxicity. Introduction • This evidence review summarizes the Genetically modified products have a growing potential health effects associated presence in the Canadian and international food with consumption of two GM animal market, with over 60 varieties of genetically products (GM Atlantic salmon and altered plants approved for safe consumption in pork) that are currently undergoing 1 Canada. This does not include fruits and food safety review in North America. vegetables whose genetic composition has been • The GM AquAdvantage® Salmon modified using conventional methods such as produces excess growth hormone, breeding and selection. Organisms that are allowing it to reach market size more bioengineered to possess a particular trait rapidly. Due to the lack of animal through insertion of a specific gene and its feeding studies, long-term effects of required components for expression of a consuming GM Atlantic salmon are functional gene product are termed transgenic or unclear. genetically modified (GM). 1 Master of Public Health Program, University of Guelph 1 Often, the insertion of a particular gene conveys a This evidence review describes the elements required to desirable trait that may enhance the nutritional value of assess safety of genetically modified animals and the food, or give the transgenic variety a survival addresses the following questions: (1) What types of advantage compared to the unmodified species. human health risks are associated with consumption of Examples include enhanced growth rate; tolerance to a genetically modified foods, in general? (2) What are the particular herbicide, insect or virus; and ability to tolerate general attitudes among Canadian consumers toward a certain environmental condition (i.e., drought). Novel genetically modified animals intended for human cellular functions that convey desirable traits are consumption? (3) What are some of the health concerns achieved through insertion of a foreign gene (i.e., that associated with consumption of transgenic animals that originated from a different species), whereas are currently undergoing food safety review? enhancement of existing functions can be realized through insertion of additional copies of host genes. Methods Some crops have also been genetically modified to suppress undesirable traits, such as the production of The Web of Knowledge Database was used to search proteins that cause allergic reactions in humans. for relevant peer-reviewed articles. The search strategy used combinations of the key words [“transgenic” OR The process to make transgenic organisms involves: (1) “genetically modified” OR “GM”] AND [“health effects” creation of a construct, which is the genetic material to OR “human health” OR “safety”]. Articles referring to be inserted; (2) transfer of the construct into a single-cell genetically modified plants were excluded, as were fertilized egg; (3) incorporation of the genetic material those describing genetic modifications to animals for the into the host genome; and (4) selection for successful purpose of vaccine or drug production. Grey literature, incorporation of the construct into the host genome. such as consumer reports, government websites and Incorporation into the host genome enables the inserted GM animal safety assessment reports, was also used. gene to be passed down from generation to generation. Bacterial and viral vectors have been used in the creation of transgenic plants such as corn2,3 and rice.4 Assessment of Novel Food By comparison, most transgenic animals have been Safety created using microinjection to introduce construct DNA into the embryo.5,6 Opting not to use viruses or transposable elements (i.e., DNA that can cut and paste Principles of the Codex Alimentarius are used internationally to guide the risk assessment process for itself at different locations in the genome) in the creation 8 of the transgenic animal reduces the potential for novel foods. The process to evaluate the risk of GM unintended movement of genetic material within the food products is based on the concept of substantial genome, which is an important safety consideration if equivalence. That is, the genetically modified product the animal or its products are intended for human must be at least as safe as its unmodified counterpart, consumption. Another aspect to consider is public and it is desirable for the GM food to be at least as perception of risks associated with consumption of GM nutritious. Given the unique nature of each genetic animal food products. modification performed, the specific parameters required to evaluate the biological impacts of the new gene will While several transgenic animals intended for human vary on a case-by-case basis. consumption are in an advanced stage of development, to date none have received safety approval for market The risk assessment process requires an extensive sale from the United States Food and Drug Adminis- analysis of complex molecules that indicate nutritional tration (FDA) or Canadian regulatory agencies. In value (i.e., omega-3 fatty acids, trans fats), vitamins and Canada, regulatory approval for transgenic foods is minerals, and molecules with biological roles that may obtained through Health Canada, and these foods are be impacted by the newly introduced gene. A weight-of- subject to the Novel Foods Regulation, under Division evidence approach that considers the outcomes 28 of the Food and Drug Regulations.7 Applications for generated from all comparative tests is then used to approval of transgenic animals for food safety are determine whether there is a substantial difference in currently treated as “new animal drugs.” Two transgenic the risk of consuming the transgenic food. animals in the development pipeline are the EnviropigTM (Ontario Pork, ON) and AquAdvantageTM Salmon (AquaBounty Technologies, Inc., MA). reactions. The nine foods that account for the vast Potential Health Risks majority of allergic reactions include peanuts, tree nuts, Associated with Genetically sesame seeds, eggs, milk, wheat, soybeans, seafood 13 and sulphites. If the newly inserted gene is derived Modified Foods from one of these foods, this should alert regulators that the transgenic food poses a greater risk for Proteins administered via the oral exposure route hypersensitive individuals compared to the non-GM generally pose a low risk because ingested proteins counterpart.14 This is illustrated in a case where a gene have low potential to be biologically active in the from the Brazil nut that encodes the protein 2S albumin bloodstream. Proteinaceous material in GM and non-GM was inserted into a soybean.15 The purpose of the foods undergoes degradation to amino acids in the modification was to improve nutritional quality; however, human stomach and intestine, and intact protein is one of the unintended effects of the transgenic soybean unlikely to enter the bloodstream since large molecules was its enhanced allergenic potential, affecting cannot be absorbed by the gut. High temperatures from individuals with hypersensitivity to Brazil nuts.15 cooking also contribute to protein denaturation. The second step may involve comparative analysis to One study that seemingly contradicted this paradigm determine amino acid sequence and/or structural reported that recombinant protein produced in GM similarity between the novel protein and proteins that are 9 maize was found in human blood. However, one of the known allergens.16 In vitro testing of purified protein main limitations of this study is that the commercial (encoded by the gene of interest) using immunoassays, antibody-based assay used to quantify the protein is and in vivo testing to assess tolerance using animal intended for use to analyze plant seeds and leaves, and models, will also indicate allergenicity potential of the 10 has been shown to perform poorly for blood analyses. protein. Animal models that are considered appropriate There may be proteins in blood that cause a false- for assessment of allergenicity include mice and rats positive test result and the study did not contain (i.e., Brown Norway rat, BALB/c mouse), dogs and negative controls (i.e., serum from individuals who had pigs.14 Proteins evaluated using in vivo models may be not been exposed to the recombinant
Load more

Recommended publications
  • Salmon with a Side of Genetic Modification: the FDA's Approval of Aquadvantage Salmon and Why the Precautionary Principle Is E
    Salmon with a Side of Genetic Modification: The FDA’s Approval of AquAdvantage Salmon and Why the Precautionary Principle is Essential for Biotechnology Regulation Kara M. Van Slyck* INTRODUCTION Over the last thirty years, once abundant wild salmon populations in the Pacific and Atlantic Oceans have declined to a mere fraction of their historic levels. As of 2016, salmon populations in Washington State’s Columbia River region are either failing to make any progress towards recovery or showing very little signs of improvement; Puget Sound salmon are only getting worse.1 In the Gulf of Maine, salmon populations dropped from five-hundred spawning adults in 1995 to less than fifty adults in 1999.2 Atlantic salmon, Salmo salar, were first designated as “endangered”3 in November 2000—the Fish and Wildlife Service (FWS) expanded the listing nine years later to include critical habitat along the coast of Maine as a result of little improvement to the population’s numbers.4 In the Pacific Ocean, FWS classified four significant salmon species as endangered for protection under the Endangered Species Act * Juris Doctor Candidate, Seattle University School of Law 2018. I would like to extend thanks to Professor Carmen G. Gonzalez for her valuable insight of the precautionary principle, her extensive knowledge on environmental regulations in the United States, and her unwavering support of this Note. 1. Governor’s Salmon Recovery Office, State of Salmon in Watersheds 2016, WASH. ST. RECREATION & CONSERVATION OFF., http://stateofsalmon.wa.gov/governors-report-2016/ [https:// perma.cc/6F3J-FKWE]. 2. Endangered and Threatened Species; Final Endangered Status for a Distinct Population Segment of Anadromous Atlantic Salmon (Salmo salar) in the Gulf of Maine, 50 C.F.R.
    [Show full text]
  • Environmental Assessment for Aquadvantage ® Salmon
    Environmental Assessment for AquAdvantage Salmon Environmental Assessment for AquAdvantage® Salmon An Atlantic salmon (Salmo salar L.) bearing a single copy of the stably integrated α-form of the opAFP-GHc2 gene construct at the α-locus in the EO-1α line Aqua Bounty Technologies, Inc. Submitted to the Center for Veterinary Medicine US Food and Drug Administration For Public Display August 25, 2010 Page 1 of 84 August 25, 2010 Environmental Assessment for AquAdvantage Salmon Table of Contents (Page 1 of 4) Title Page ............................................................................................................................. 1 Table of Contents ................................................................................................................. 2 List of Tables ....................................................................................................................... 6 List of Figures ...................................................................................................................... 6 List of Acronyms & Abbreviations ..................................................................................... 7 List of Definitions ................................................................................................................ 9 Summary ............................................................................................................................. 10 1.0 INTRODUCTION ..................................................................................................
    [Show full text]
  • STUDY on RISK ASSESSMENT: APPLICATION of ANNEX I of DECISION CP 9/13 to LIVING MODIFIED FISH Note by the Executive Secretary INTRODUCTION 1
    CBD Distr. GENERAL CBD/CP/RA/AHTEG/2020/1/3 19 February 2020 ENGLISH ONLY AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT Montreal, Canada, 31 March to 3 April 2020 Item 3 of the provisional agenda* STUDY ON RISK ASSESSMENT: APPLICATION OF ANNEX I OF DECISION CP 9/13 TO LIVING MODIFIED FISH Note by the Executive Secretary INTRODUCTION 1. In decision CP-9/13, the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety decided to establish the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, which would work in accordance with the terms of reference contained in annex II to that decision. In the same decision, the Conference of the Parties serving as the meeting of the Parties to the Protocol requested the Executive Secretary to commission a study informing the application of annex I of the decision to (a) living modified organisms containing engineered gene drives and (b) living modified fish and present it to the online forum and the AHTEG. 2. Pursuant to the above, and with the financial support of the Government of the Netherlands, the Secretariat commissioned a study informing the application of annex I to living modified fish to facilitate the process referred to in paragraph 6 of decision CP-9/13. The study was presented to the Open-Ended Online Forum on Risk Assessment and Risk Management, which was held from 20 January to 1 February 2020, during which registered participants provided feedback and comments.1 3.
    [Show full text]
  • Genetically Engineered Fish: an Unnecessary Risk to the Environment, Public Health and Fishing Communities
    Issue brief Genetically engineered fish: An unnecessary risk to the environment, public health and fishing communities On November 19, 2015, the U.S. Food & Drug Administration announced its approval of the “AquAdvantage Salmon,” an Atlantic salmon that has been genetically engineered to supposedly be faster-growing than other farmed salmon. This is the first-ever genetically engineered animal allowed to enter the food supply by any regulatory agency in the world. At least 35 other species of genetically engineered fish are currently under development, including trout, tilapia, striped bass, flounder and other salmon species — all modified with genes from a variety of organisms, including other fish, coral, mice, bacteria and even humans.1 The FDA’s decision on the AquAdvantage genetically engineered salmon sets a precedent and could open the floodgates for other genetically engineered fish and animals (including cows, pigs and chickens) to enter the U.S. market. Genetically engineered salmon approved by FDA Despite insufficient food safety or environmental studies, the FDA announced its approval of the AquAdvantage Salmon, a genetically engineered Atlantic salmon produced by AquaBounty Technologies. The company originally submitted its application to the FDA in 2001 and the FDA announced in the summer of 2010 it was considering approval of this genetically engineered fish — the first genetically engineered animal intended for human consumption. In December 2012, the FDA released its draft Environmental Assessment of this genetically engineered salmon, and approved it in November 2015. This approval was made despite the 1.8 million people who sent letters to FDA opposing approval of the so-called “frankenfish,” and the 75 percent of respondents to a New York Times poll who said they would not eat genetically engineered salmon.2 The FDA said it would probably not require labeling of the fish; however Alaska, a top wild salmon producer, requires labeling of genetically engineered salmon and momentum is growing for GMO labeling in a number of states across the U.S.
    [Show full text]
  • Transgenic Fish Technology and Its Application in Aquaculture
    * TRANSGENIC FISH TECHNOLOGY AND ITS APPLICATION IN AQUACULTURE Dr . G. B. CHAND Associate Professor Department of Zoology Aquatic Toxicology laboratory Patna University, Patna Email : [email protected] * Transgenic Fishes : Introduction . Organisms into which heterologous DNA (transgene) has been artificially introduced and integrated in their genomes are called transgenics. Genetically modified fish (GM fish) are organisms from the taxonomic clade which includes the classes Agnatha (jawless fish), Chondrichthyes (cartilaginous fish) and Osteichthyes (bony fish) whose genetic material (DNA) has been altered using genetic engineering techniques. In most cases, the aim is to introduce a new trait to the fish which does not occur naturally in the species, i.e. transgenesis. GM fish are used in scientific research and kept as pets. They are being developed as environmental pollutant sentinels and for use in aquaculture food production. In 2015, the Aqua-Advantage salmon was approved by the US Food and Drug Administration (FDA) for commercial production, sale and consumption, making it the first genetically modified animal to be approved for human consumption. Some GM fish that have been created have promoters driving an over-production of "all fish" growth hormone. This results in dramatic growth enhancement in several species, including salmonids, (Shao et al.,1992) carps (Robert et al.,2001) and Tilapias(Rahman et al.,2005; Hackett and Alvarez,2000). TRANSGENIC FISHES: INTRODUCTION . The first transgenic fish were produced in China in 1985( Dunham & Winn,2014). As of 2013, approximately 50 species of fish have been subject to genetic modification. This has resulted in more than 400 fish/trait combinations. Most of the modifications have been conducted on food species, such as Atlantic salmon (Salmo solar), tilapia (genus) and common carp (Cyprinus carpio).[Menozzi et al.,2013] What can transgenic technology offer? .
    [Show full text]
  • Transgenic Animals
    0( (-) 00 e_ ,Z5-1 Project Number: IQP — 43 — DSA — 9195 —5904 —0822 TRANSGENIC ANIMALS An Interactive Qualifying Project Report Submitted to the faculty of the WORCESTER POLYTECHNIC INSTITUTE In partial fulfillment of the requirements for the Degree of Bachelor of Science By Nicholas Far ey Scott LeBlanc Robert Redden Date: March 2, 2000 APPROVED: 1. transgenic 2. biotechnology 3. gene transfer Professor David S. Adams Project Advisor ABSTRACT This project investigated the use of transgenic animals in recent experiments and the effects of this novel technology on society. Using scientific journals and web resources, we examined the transgenic animals in existence, their uses, and the surrounding ethical and social issues. Recommendations were offered on which experiments involving transgenic animals should be continued and how to apply this new technology to the fields of science and medicine. ii TABLE OF CONTENTS SECTION PAGE Signature Page Abstract Table of Contents iii Executive Summary vii Project Objective xi List of Illustrations xii Introduction xiii 1. BACKGROUND AND HISTORY 1 1.1 Background Information 1 1.1.1 DNA 1 1.1.2 Replication and Expression 2 1.2 History of Transgenics 3 1.2.1 Prior to the First Transgenic Animal 3 1.2.2 The First Transgenic Animals 4 1.2.3 Further Experiments in the 1980's 5 1.2.4 Experiments Spanning into the Present 7 2. CURRENT METHODS 10 2.1 Superovulation 10 2.1.1 Choice of Parental Donor Strain 10 2.1.2 Hormone Cycle 11 2.1.3 Methods of Superovulation 13 iii 2.1.4 Flushing 14 2.2 Methods of Gene Transfer 17 2.2.1 Obtaining Recombinant DNA 17 2.2.2 Retroviral Vectors 19 2.2.3 Microinjection 20 2.2.4 Embryonic Stem Cells for Injections 22 2.2.5 Cultured Sperm Cells as Vectors 27 2.3 Transgenic Embryo Implantation 27 2.3.1 Embryo Inspection 27 2.3.2 Embryo Implantation Methods 28 2.3.3 Testing and Breeding 30 3.
    [Show full text]
  • The Development of Genetically Modified (GM) Salmon in Canada
    The Development of Genetically Modified (GM) Salmon in Canada In late 2013, Environment Canada approved the commercial production of genetically modified (GM, also called genetically engineered), Atlantic salmon in Canada. In November 2015 it was approved for human consumption in the United States and then in May 2016, it was approved for human consumption in Canada, making it the first genetically modified food animal approved anywhere in the world. The US company, AquaBounty (now a majority owned subsidiary of Intrexon), currently runs a facility in PEI where it has been producing GM salmon eggs for research. The company plans to produce GM salmon eggs in PEI and ship the eggs to Panama for commercial grow-out and processing, but Environment Canada’s approval also allows the company to grow out the fish in Canada. The company has also signaled its interest in expanding facilities to other countries and has started trials in Brazil and Argentina. The Atlantic salmon was genetically engineered with a growth hormone gene from Chinook salmon and genetic material from ocean pout (an eel-like fish), to grow faster than other farmed salmon. Canadian research indicates that GM salmon could out- compete wild Atlantic salmon for food and other resources. All regulatory decisions on genetically modified organisms in Canada are made without public consultation. Environmental Threats Genetic modification/engineering allows for the transfer of genetic material directly from one organism to another, across the species and kingdom barriers (for example from plant to animal) at the molecular level, and is dramatically different from traditional animal breeding. It can have unpredictable impacts on the organism and carries unknown risks for the ecosystem if the animal escapes into the wild.
    [Show full text]
  • Transgenic Animals
    IQP-43-DSA-4208 IQP-43-DSA-6270 TRANSGENIC ANIMALS An Interactive Qualifying Project Report Submitted to the Faculty of WORCESTER POLYTECHNIC INSTITUTE In partial fulfillment of the requirements for the Degree of Bachelor of Science By: _________________________ _________________________ William Caproni Erik Dahlinghaus August 24, 2012 APPROVED: _________________________ Prof. David S. Adams, PhD WPI Project Advisor ABSTRACT A transgenic animal contains genes not native to its species. The use of these animals in research and medicine has dramatically increased our understanding of genetics and disease modeling. This IQP aims to provide an overview of the technical development and applications of transgenic animals, as well as the ethical, legal, and societal ramifications of creating these animals. Finally, this IQP will draw conclusions from the research performed and the information gathered. 2 TABLE OF CONTENTS Signature Page …………………………………………..…………………………….. 1 Abstract …………………………………………………..……………………………. 2 Table of Contents ………………………………………..…………………………….. 3 Project Objective ……………………………………….....…………………………… 4 Chapter-1: Transgenic Animal Technology …….……….…………………………… 5 Chapter-2: Applications of Transgenics in Animals …………..…………………….. 19 Chapter-3: Transgenic Ethics ………………………………………………………... 32 Chapter-4: Transgenic Legalities ……………………..………………………………. 43 Project Conclusions...…………………………………..….…………………………… 53 3 PROJECT OBJECTIVES The objective of this project was to research and present a multifaceted view of transgenics, including the technology itself and its effects on mankind. Chapter one offers an overview of the different methods for creating and testing transgenic animals. Chapter two provides information on how the different types of transgenic animals are used, and how they affect our daily lives. Chapter three presents the many ethical issues surrounding this controversial technology, and its impact on society. Chapter four describes the legal issues regarding this emerging technology and the patenting of life.
    [Show full text]
  • TRANSGENIC SALMON IS FRAUGHT with UNCERTAINTIES and IRREVERSIBLE HARMFUL CONSEQUENCES 2.Pdf
    www.theguardian.com TRANSGENIC SALMON IS FRAUGHT WITH UNCERTAINTIES AND IRREVERSIBLE HARMFUL CONSEQUENCES. In May 2016, the Canadian Food Inspection Agency approved the sale of the GM fish. In July 2017, AquaBounty Technologies said they had sold 4.5 tons of AquaAdvantage salmon fillets to customers in Canada. AquaBounty first asked the FDA to approve the fish for human consumption in 1996. But the FDA said because this was the first genetically modified animal that would be eaten by humans, the agency wanted to take it slow and weigh the pros and cons.Nov 19, 2015 Aquadvantage salmon FDA Approval The Food and Drug Administration (FDA) approved AquaBounty Technologies' application to sell the AquAdvantage salmon to U.S. consumers on November 19, 2015. ... The decision marks the first time a genetically modified animal has been approved to enter the United States food supply. The AquaBounty transgenic Salmon are only allowed to be raise in two land-bases tanks Submission to the FDA TRANSGENIC SALMON IS FRAUGHT WITH UNCERTAINTIES AND IRREVERSIBLE HARMFUL CONSEQUENCES. Sunday, 20 October 2013 21:54 By Joan Russow PhD Global Compliance Research Project It is reported that the FDA is poised to approve Genetically engineered Aquabounty Salmon for human consumption; If approved, it would be the first-ever GE animal permitted for human consumption in the U.S. On April 26 2013 the 120-day comment period ended with 1.8 million submissions opposing the approval of Aquabounty salmon. Once approved, will it be exported everywhere? Unless there is a global ban on genetically engineered food and crops, global citizens will have to be constantly vigilant and have to oppose over and over again each new product introduced by this rogue technology.
    [Show full text]
  • The Aquadvantage Salmon: Who Owns Escaped Genetically Modified Animals? Matthew Orm Gan University of Maine School of Law
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by University of Maine, School of Law: Digital Commons Ocean and Coastal Law Journal Volume 17 | Number 1 Article 6 2011 The Aquadvantage Salmon: Who Owns Escaped Genetically Modified Animals? Matthew orM gan University of Maine School of Law Follow this and additional works at: http://digitalcommons.mainelaw.maine.edu/oclj Recommended Citation Matthew Morgan, The Aquadvantage Salmon: Who Owns Escaped Genetically Modified Animals?, 17 Ocean & Coastal L.J. (2011). Available at: http://digitalcommons.mainelaw.maine.edu/oclj/vol17/iss1/6 This Comment is brought to you for free and open access by the Journals at University of Maine School of Law Digital Commons. It has been accepted for inclusion in Ocean and Coastal Law Journal by an authorized administrator of University of Maine School of Law Digital Commons. For more information, please contact [email protected]. THE AQUADVANTAGE SALMON: WHO OWNS ESCAPED GENETICALLY MODIFIED ANIMALS? Matthew Morgan* I. INTRODUCTION It is likely that the last Atlantic salmon you ate was not caught from the depths of the Atlantic Ocean. In fact, it is highly probable that the salmon was never caught at all. The vast majority of Atlantic salmon sold in the United States is “farm raised” salmon, which are salmon that never swim freely in any body of water other than a fish pen.1 This system of fish farming is known as aquaculture. The global production of salmon, which exceeded one million tons in 2008, is the top aquaculture money maker.2 Moreover, aquaculture accounts for seventy- three percent of global salmon production.3 Aquaculture allows for greater control of production and also helps deter the overfishing of already fragile wild Atlantic salmon populations.4 Increasingly, however, the aquaculture process has been subject to criticisms relating to the prevalence of disease and sea lice in its products, the frequency of * Research Editor, Ocean and Coastal Law Journal, University of Maine School of Law, expected graduation 2012.
    [Show full text]
  • Swimming Upstream: the Eedn to Resolve Inconsistency in the FDA's Fishy Regulatory Scheme Kelsie Kelly
    Journal of Law and Policy Volume 27 | Issue 1 Article 5 Fall 10-1-2018 Swimming Upstream: The eedN to Resolve Inconsistency in the FDA's Fishy Regulatory Scheme Kelsie Kelly Follow this and additional works at: https://brooklynworks.brooklaw.edu/jlp Part of the Agriculture Law Commons, Food and Drug Law Commons, and the Science and Technology Law Commons Recommended Citation Kelsie Kelly, Swimming Upstream: The Need to Resolve Inconsistency in the FDA's Fishy Regulatory Scheme, 27 J. L. & Pol'y 185 (2018). Available at: https://brooklynworks.brooklaw.edu/jlp/vol27/iss1/5 This Note is brought to you for free and open access by the Law Journals at BrooklynWorks. It has been accepted for inclusion in Journal of Law and Policy by an authorized editor of BrooklynWorks. S"I11IN4 $PS%&6,17 %36 N66) %( &6S(L#6 IN*(NSIS%6N*0 IN %36 5),'S 5IS30 &64$L,%(&0 S*3616 Kelsie Kelly* The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation. As the technology used to develop food has advanced, the outermost limits of the current regulatory framework are being tested. The result has been a circuitous and ineffective attempt to regulate transgenic organisms, intended for human consumption, using multiple agencies and a patchwork of laws. The ability to incorporate DNA from nearly any organism into the genome of another provides immense potential for innovative new food products, but may also allow for unintended health and environmental consequences. Proper regulation of genetically engineered organisms is necessary in order to safely and effectively utilize biotechnology to benefit the American people.
    [Show full text]
  • 1 Draft Study on Risk Assessment
    1 2 DRAFT STUDY ON RISK ASSESSMENT: APPLICATION OF ANNEX I OF DECISION CP 3 9/13 TO LIVING MODIFIED FISH 4 5 6 Report for the Secretariat of the Convention on Biological Diversity, UN Environment 7 Programme 8 9 December 2019 10 11 Jeremy B Sweet, 12 JT Environmental Consultants Ltd, 13 6 Green Street, Willingham, Cambridge, UK 14 15 With expert scientific advice on sections 5 and 6 from: 16 Dr Robert H Devlin, Fisheries and Oceans Canada, West Vancouver, Canada 17 Dr Fredrik L Sundström, University of Uppsala, Sweden 18 19 20 21 DRAFT 20/12/2019 22 23 24 25 26 27 28 29 30 31 32 33 2 DRAFT FOR ONLINE DISCUSSIONS – NOT FOR CITATION 1 Contents 2 3 1. Terms of Reference 4 5 2. List of abbreviations 6 7 3. Executive Summary 8 9 4. Methods 10 4.1 Literature Review 11 4.2 Gathering information from National Biosafety Authorities, Institutions and Stakeholders 12 13 5. Literature Review 14 5.1 Background 15 5.2 Transformed Fish species 16 5.3 Transgenic Traits 17 5.3.1 Enhanced Growth 18 5.3.2 Fatty Acid Composition – Production of Omega-3. 19 5.3.3 Enhanced and Double Muscle 20 5.3.4 Disease Resistance 21 5.3.4.1 Virus Diseases 22 5.3.4.2 Bacterial Diseases 23 5.3.5 Biocontainment 24 5.3.5.1 Fertility reduction and sterility 25 5.3.5.2 Reduced Viability 26 5.3.6 Cold Tolerance 27 5.3.7 Fluorescence and Colour changes in LMF 28 5.3.8 Transgenic Biosensors, Bio-indicators and Biomedical uses of LMF 29 5.4 Biological control of Fish 30 31 6.
    [Show full text]